PROJECT SUMMARY C-Path was created in 2005 under the auspices of the Critical Path Initiative to catalyze advances in medical innovation and regulatory science by leading teams of stakeholders from academia, industry, government, and advocacy organizations and promoting the sharing of data, knowledge and expertise in order to produce sound, consensus-based science. C-Path's successes include the creation of cooperative consortia, the qualification of new drug development tools (DDTs), the endorsement of fit-for-purpose disease progression models and clinical trial simulation tools, the generation of new data standards and databases, and the creation of educational initiatives that advance regulatory science. With renewed funding C-Path will be able to continue developing Critical Path Public-Private Partnerships and advancing innovative, collaborative projects in research, education, and outreach for fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.